Enrollment Begins in MARRS Pivotal Trial of Perfuze Millipede System

November 7, 2023—Perfuze, an Ireland-based medical device company developing technology to treat acute ischemic stroke, recently announced commencement of enrollment in its pivotal MARRS clinical study.

The first patient in the MARRS study was enrolled by David Fiorella, MD, Director of the Stony Brook Cerebrovascular Center at Stony Brook University Hospital in Stony Brook, New York.

“I am delighted to begin enrollment in the MARRS pivotal study” commented Dr. Fiorella in the Perfuze press release. “It is an exciting opportunity to evaluate the next wave of thrombectomy technology with the possibility of improving interventional stroke treatment. I anticipate the results of this study will benefit future stroke patients.”

According to the company, MARRS is an interventional, open-label, single-arm, multicenter, prospective pivotal study evaluating the performance and safety of the company’s Millipede system in patients with acute ischemic stroke.

Investigators will enroll up to 220 patients at 25 sites across the United States and Europe. Results of the study are intended to provide clinical evidence to support an application for FDA clearance.

The study’s Principal Investigators are Ameer Hassan, DO, with Valley Baptist Medical Center in Harlingen, Texas, and Marc Ribo, MD, with Vall d’Hebron Hospital in Barcelona, Spain.

“Superbore aspiration has the potential to significantly improve reperfusion in stroke patients, and the Millipede system represents an elegant approach to treatment,” commented Dr. Hassan in the company’s press release.

The company noted that its Superbore aspiration technology has a 50% increase in surface area at the catheter tip to facilitate increased vacuum power and is designed to navigate complex neurovascular anatomy.

In 2022, the Perfuze Millipede 088 access catheter received FDA 510(k) clearance for neurovascular access. In 2021, Perfuze announced CE Mark approval of Millipede 088 for first-line aspiration thrombectomy in the European Union.